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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Information Request, Product Quality, August 12, 2011 - Gintuit


  1. Please provide a comprehensive table that lists the location of all information present in existing FDA regulatory files on Apligraf (PMA) or CelTx (IDEs, BLA) relevant to growth factor, cytokine or extracellular matrix protein released by the final product. Both non-clinical and clinical information should be included.
  1. Please provide a comprehensive table that lists all of the fibroblast and keratinocyte cell banks that have been used for the manufacture of Apligraf to date and of CelTx during the IDE studies. In the table, please also include the following information:
    1.  S/N and submission date of the supplement to the FDA file that contains the testing data
    1. An indication of any points at which the testing of the cell banks were modified
  1. Please provide the validation reports of analytical procedures for the following final product release specifications outlined in Table 3.2.P.5.1-1 of the BLA submission:
    1. QCP-072- Mycoplasma, performed by -----b(4)--------------------------
    1. QCP-002- Sterility USP <71> (Bacteriostasis / Fungistasis test), performed by      ----b(4)---------------------------------------------. Only the summary of tests has been provided.
    1. QCP-053- Visual inspection